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Pediatric Anesthesia ISSN 1155-5645

ORIGINAL ARTICLE

An in vitro and in vivo validation of a novel monitor for
intracuff pressure in cuffed endotracheal tubes
Archana S. Ramesh1, Senthil G. Krishna1,2, William T. Denman3 & Joseph D. Tobias1,2,4
1
2
3
4

Department of Anesthesiology & Pain Medicine, Nationwide Children’s Hospital, Columbus, OH, USA
Department of Anesthesiology & Pain Medicine, The Ohio State University, Columbus, OH, USA
Department of Anesthesiology, The Massachusetts General Hospital, Boston, MA, USA
Department of Pediatrics, Nationwide Children’s Hospital, The Ohio State University, Columbus, OH, USA

Keywords
intracuff pressure; cuffed endotracheal
tube; pediatric anesthesia
Correspondence
Joseph D. Tobias, Department of
Anesthesiology & Pain Medicine,
Nationwide Children’s Hospital, 700
Children’s Drive, Columbus, OH 43205,
USA
Email: Joseph.Tobias@Nationwidechildrens.
org
Section Editor: Brian Anderson
Accepted 30 June 2014
doi:10.1111/pan.12498

Summary
Background: The clinical practice of pediatric anesthesiology has changed
with increasing use of cuffed endotracheal tubes (cETTs) in infants and children. To limit the risk of tracheal mucosal damage, regular monitoring of intracuff pressure (CP) is necessary. This study evaluates the efficacy and
accuracy of a novel syringe device that provides a digital readout of the CP.
Methods: The study was conducted in two phases. In phase 1, an in vitro
study, cETTs of sizes 4.0, 5.0, and 6.0 mm ID were placed into polyvinylchloride tubing of appropriate sizes. The cuffs were then inflated, and the CP was
measured simultaneously using the syringe device and a manometer. In phase
2, an in vivo study on 200 pediatric patients, the syringe device and the
manometer were simultaneously attached to the pilot balloon to measure the
CP following endotracheal intubation. Statistical analysis included linear
regression analysis and Bland–Altman comparison.
Results: Linear regression analysis of the in vitro study demonstrated an R2
value of 0.9989. Bias and precision were 1.92  0.62 with 95% level of
agreement (LOA) ranging from 3.13 to 0.72. For the in vivo study, the linear regression analysis demonstrated an R2 value of 0.9943. The bias and precision were 0.53  0.68 with 95% LOA ranging from 1.86 to 0.81.
Conclusion: The study has demonstrated clinically acceptable correlation
between the CPs obtained from the standard manometer and the syringe
device both in vitro and in vivo. This device is a simple, reliable, portable, and
affordable method to monitor CP.

Introduction
The clinical practice of pediatric anesthesiology has
changed with an increase in the use of cuffed endotracheal tubes (ETTs) even in infants and children (1,2).
Although there have been significant improvements in
the technology and design of these cuffed ETTs in the
recent years making them safer to use in the pediatric
population, there remains a concern regarding the
effects of excessive cuff pressure on the tracheal mucosa
(3–6). Despite this, there may be little attention paid to
the inflation of the cuff following endotracheal intubation and the measurement of the intracuff pressure (7).
© 2014 John Wiley & Sons Ltd
Pediatric Anesthesia 24 (2014) 1005–1008

Part of this may be due to the fact that manometers are
not readily available in every location where endotracheal intubation occurs. The current study prospectively
evaluates the efficacy of a simple and portable novel syringe device (AnapnoGuardCuffill, Hospitech Repsiration; Kiryat Matalone, Petach-Tikva, Israel) that
provides a digital readout of the intracuff pressure
(Figure 1).
Methods
This study was reviewed and approved by the Institutional Review Board of Nationwide Children’s Hospital,
1005

Intracuff pressure monitoring

A.S. Ramesh et al.

Figure 1 Photograph of the syringe device used in the current
study. It provides a digital readout of the intracuff pressure.

Columbus, Ohio on 10/25/2013 (IRB13-00741), and the
need for informed consent was waived. There was no
change in the clinical practice dictated for these patients.
The study was conducted in two phases. Phase one was
an in vitro study where cuffed ETTs of sizes 4.0, 5.0 and
6.0 mm ID were placed into progressively larger pieces
of polyvinylchloride tubing. The cuffs were then inflated
to various intracuff pressures. The intracuff pressure
was measured simultaneously using the syringe device
and a standard manometer (Posey Cufflator Endotracheal Tube Inflator and ManometerTM; JT Posey Company, Arcadia, CA, USA). A total of 100 simultaneous
pressure readings were obtained from each of the three
sizes of the ETTs. Phase two of the study was an in vivo
study where the syringe device and the manometer were
simultaneously attached to the pilot balloon to measure
the intracuff pressure following endotracheal intubation
in a cohort of pediatric patients presenting for general
anesthesia during surgical interventions. Additional data
collected included the patient’s demographic data (age,
weight, and gender), and the size of the ETT. Statistical
analysis included a comparison of the intracuff pressures
measured by the syringe device and the manometer
using a linear regression analysis as well as a Bland–Altman analysis. The latter was used to determine the bias,
precision, and level of agreement (LOA).
Results
For the in vitro part of the study, there were 100 simultaneous readings from each of the three sizes of the ETT.
The linear regression analysis demonstrated an R2 value
of 0.9989, and the Bland–Altman revealed a bias and

precision of 1.92  0.62 cmH2O with 95% cmH2O
LOA ranging from 3.13 to 0.72 cmH2O (Table 1;
Figures 2 and 3). No difference in the accuracy of the
device was noted across the results for 4.0, 5.0, and
6.0 mm ID ETTs (Table 1). The in vivo study was conducted on 200 pediatric patients ranging in age from 0.3
to 18 years (5.2  4.3 years) and in weight from 5.18 to
119.5 kg (26.2  21.6 kg). There were 134 boys and 66
girls. The size of the ETTs used ranged from 3.0 to
7.0 mm ID. The linear regression analysis demonstrated
an R2 value of 0.9943 (Figure 4). The Bland–Altman
revealed a bias and precision of 0.53  0.68 cmH2O
with 95% cmH2O LOA ranging from 1.86 to 0.81
cmH2O (Figure 5). No difference in the accuracy of the
device was noted based on the age of the patient or the
size of the ETT used in vivo (Tables 2 and 3).
Discussion
The current study prospectively demonstrates that the
syringe device in question can be used to provide a clinically acceptable measurement of the intracuff pressure
following endotracheal intubation using a cuffed ETT.
This device provides a digital readout of the exact intracuff pressure, has an automatic shutdown, and is FDA
and CE approved. The device is built into a 10-ml syringe to allow for it to be used to inflate the cuff as well
as simultaneously measure the intracuff pressure.
Although it is disposable and ideal for single patient use,
it can provide up to 100 readings. This was noted in our
study as the entire study was performed with fewer than
five devices. Although Bland–Altman analysis demonstrated occasional values outside the 95% LOA, overall
the reliability and accuracy were acceptable for clinical
care. When compared to the standard manometer, this
syringe device is significantly less expensive ($8 vs $300)
and can therefore be used in various locations away
from the operating room including interhospital patient
transport or by emergency medical personnel such as
paramedics who provide care outside of the hospital setting. In hospitals with numerous operating rooms and
multiple locations of intubation, it may not be practically feasible or cost-effective to have a manometer at

Table 1 Bland–Altman analysis and linear regression analysis for in vitro data

Parameter
R2 value
Bias  precision (cmH2O)
Level of agreement (cmH2O)

1006

4.0 mm ID cETT

5.0 mm ID cETT

6.0 mm ID cETT

0.9993
1.83  0.59
2.98 to 0.68

0.9991
1.88  0.59
3.04 to 0.72

0.9986
2.06  0.65
3.33 to 0.79

Total (300 data
points)
0.9989
1.92  0.62
3.13 to 0.72

© 2014 John Wiley & Sons Ltd
Pediatric Anesthesia 24 (2014) 1005–1008

A.S. Ramesh et al.

Figure 2 Linear regression analysis for in vitro comparison of intracuff measurements obtained from the manometer and the syringe
device in phase one of the study.

Figure 3 Bland–Altman analysis for in vitro comparison of intracuff
measurements obtained from the manometer and the syringe device
in phase one of the study. The bias (dashed line) and precision (dotted line) are noted on the graph.

every site. Also, with repeated use in a busy operating
room environment, these manometers may become
damaged or lost. The current device may provide an
alternative option in such scenarios.
Despite the shift in the practice with the routine use of
cuffed ETTs in many pediatric operating rooms, we find
that there has been limited attention focused on the optimal means of inflating the cuff and on methods to
ensure that the intracuff pressure is within an acceptable
range. The current device seems to fill that gap in clinical
practice and allows an instantaneous and accurate
measurement of the intracuff pressure. Despite the
improvements in the technology of the cuff, excessive
inflation with a high intracuff pressure may still lead to
© 2014 John Wiley & Sons Ltd
Pediatric Anesthesia 24 (2014) 1005–1008

Intracuff pressure monitoring

Figure 4 Linear regression analysis for in vivo comparison of intracuff measurements obtained from the manometer and the syringe
device in phase two of the study.

Figure 5 Bland–Altman analysis for in vivo comparison of intracuff
measurements obtained from the manometer and the syringe device
in phase two of the study. The bias (dashed lined) and precision
(dotted) line are noted on the graph.

damage of the tracheal mucosa with a potential to cause
postoperative respiratory compromise (8). This mandates measurement of the intracuff pressure following
initial placement and periodically throughout the time
that the cETT is left in place.
Although various clinical techniques have been
claimed as acceptable and safe means of inflating the
cuff to ensure that the intracuff pressure is within the
clinically desired range, some direct measurement of
the intracuff pressure is now being suggested as our
clinical practice has changed (9). Although this can be
1007

Intracuff pressure monitoring

A.S. Ramesh et al.

Table 2 Bland–Altman analysis and linear regression analysis for in vivo data

Parameter
R2 value
Bias  precision
(cmH2O)
Level of agreement
(cmH2O)

3.0–3.5 mm
ID cETT
(31 patients)

4.0–4.5 mm
ID cETT
(91 patients)

5.0–5.5 mm
ID cETT
(37 patients)

R2 value
Bias  precision
(cmH2O)
Level of agreement
(cmH2O)

7.0–7.5 mm
ID cETT
(15 patients)

Total in vivo data
(200 patients)

0.9935
0.65  0.49

0.9940
0.49  0.69

0.9937
0.49  0.73

0.9916
0.65  0.80

0.9960
0.33  0.62

0.9943
0.53  0.68

1.60 to 0.31

1.85 to 0.86

1.92 to 0.95

2.22 to 0.91

1.54 to 0.88

1.86 to 0.81

Table 3 Bland–Altman analysis and linear regression analysis based
on age

Parameter

6.0–6.5 mm
ID cETT
(26 patients)

≤8 years
(160 patients)

>8 years
(40 patients)

0.9941
0.51  0.65

0.9927
0.60  0.78

1.79 to 0.78

2.13 to 0.92

accomplished by having a manometer in every location
in which endotracheal intubation occurs, the cost of
these devices may be prohibitive. To allow the measurement of intracuff pressure without a costly and somewhat large and cumbersome device, recent devices have
entered the clinical market including the syringe device
evaluated in the current study. In addition to its accuracy that has been demonstrated in the current study, its
advantages include its low cost and size thereby allowing
its easy transport to various locations including its use
outside of the hospital setting. However, a drawback
with this device is that continuous cuff pressure moni-

toring is not feasible. Also when compared to electronic
or pneumatic cuff pressure regulators, this syringe does
not regulate the cuff pressure within the desired range
automatically.
In summary, this study has demonstrated a clinically
acceptable correlation between the intracuff pressure
readings obtained from the standard manometer and
the syringe cuff pressure measurement device both
in vitro and in vivo. The syringe device is simple, reliable,
portable, and affordable method to obtain instantaneous intracuff pressure measurements.
Acknowledgments
This research was carried out without funding.
Conflict of interest
Dr. Denman has received payment for technical and
clinical advisory services to Hospitech Respiration, Kiryat Matalone, Petach-Tikva, Israel. Dr. Denman owns
equity ownership in Hospitech Respiration.

References
1 Eschertzhuber S, Salgo B, Schmitz A et al.
Cuffed endotracheal tubes in children reduce
sevoflurane and medical gas consumption and
related costs. Acta Anaesthesiol Scand 2010;
54: 855–858.
2 Khine HH, Corddry DH, Kettrick RG et al.
Comparison of cuffed and uncuffed endotracheal tubes in young children during general
anesthesia. Anesthesiology 1997; 86: 627–633.
3 Weiss M, Dullenkopf A, Fischer JE et al. Prospective randomized controlled multi-centre
trial of cuffed or uncuffed endotracheal tubes
in small children. European Paediatric

1008

Endotracheal Intubation Study Group. Br J
Anaesth 2009; 103: 867–873.
4 Weiss M, Dullenkopf A. Cuffed tracheal tubes
in children: past, present and future. Expert
Rev Med Devices 2007; 4: 73–82.
5 Nordin U. The trachea and cuff induced tracheal injury. An experimental study on causative factors and prevention. Acta Otolaryngol
1976; 345(Suppl): 1–71.
6 Seegobin RD, Hasselt GL. Endotracheal cuff
pressure and tracheal mucosal blood flow:
endoscopic study of effects of four large cuff
volumes. Br Med J 1984; 288: 965–968.

7 Tobias JD, Schwartz L, Rice J et al. Cuffed
endotracheal tubes in infants and children:
should we routinely measure the cuff pressure?
Int J Pediatr Otorhinolaryngol 2012; 76: 61–63.
8 Sathyamoorthy MK, Lerman J,
Lakshminrusimha S et al. Inspiratory stridor
after tracheal intubation with a Microcuffâ
tracheal tube in three young infants. Anesthesiology 2013; 118: 748–750.
9 Tobias JD, Gopalakrishnan S, Rice J et al.
Cuffed endotracheal tubes in infants and children: a technique to ensure an acceptable intracuff pressure. ICU Dir 2013; 4: 62–64.

© 2014 John Wiley & Sons Ltd
Pediatric Anesthesia 24 (2014) 1005–1008